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Can talk therapy for sleep beat cancer fatigue?

NCT ID NCT05226078

Symptom relief Sponsor: Abramson Cancer Center at Penn Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests whether cognitive behavioral therapy for insomnia (CBT-I) can reduce cancer-related fatigue in breast cancer patients who also have chronic insomnia. Participants receive different doses of CBT-I, which focuses on changing sleep habits and thoughts. The study aims to see if the therapy is acceptable, feasible, and effective in improving sleep and fatigue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive Behavioral Therapy for Insomnia (CBT-I)
What this could lead to
If effective, this could point toward a tailored, non-drug approach to reduce fatigue and improve sleep in breast cancer patients.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not apply broadly. The therapy requires commitment, and benefits may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

64 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The diagnosis of organ-confined BC; 2. Treatment with RT; 3. Willingness and ability to provide informed consent; 4. They endorse problems with both insomnia and CRF, as determined by a score within the significant ranges on the ISI, PROMIS 7a, BFI, and FACIT-F; 5. and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD). Exclusion Criteria: 1. History of untreated obstructive sleep apnea (OSA \[defined as an apnea-hypopnea index ≥ 10\]) or above threshold scores on the STOP-BANG; 2. History of narcolepsy; 3. Night shift work; 4. Distant metastatic disease at presentation; 5. Active alcohol and/or drug dependence; 6. They do not have a diagnosis of BC; 7. They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT; 8. They have a current diagnosis of significant medical and/or psychiatric disorders; 9. And/or they are not between the ages of 25-85 years.

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Conditions

The condition(s) this trial relates to.

breast cancer cancer-related condition Fatigue insomnia neoplasm neoplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer-related problem/condition Cancer-related syndrome Chronic insomnia

Contacts and locations

Locations

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.